Condition category
Digestive System
Date applied
09/01/2015
Date assigned
21/01/2015
Last edited
21/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Infectious diarrhoea is a major threat to human health and treatment with antibiotics has led to resistant bacteria. Prevention and management of dehydration is standard care but does not reduce the duration of diarrhoea. The aim in this study is to assess the usefulness of a plant extract (LiveXtract) in reducing the duration of diarrhoea in children and adults.

Who can participate?
Male patients, age 6 months old to 60 years old, presenting with acute diarrhoea

What does the study involve?
Patients will be randomly allocated to one of two groups: LiveXtract mixed with ORS or water mixed with ORS. They will be monitored for up to 4 days.

What are the possible benefits and risks of participating?
A benefit is the reduction in the duration of diarrhoea. A risk might be a reaction to the LiveXtract solution.

Where is the study run from?
Dhaka Hospital (Bangladesh)

When is the study starting and how long is it expected to run for?
From July 2011 to October 2017

Who is funding the study?
LiveLeaf Inc (USA)

Who is the main contact?
Dr Thomas Lawson
tlawson@liveleaf.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas Lawson

ORCID ID

http://orcid.org/0000-0001-5182-4681

Contact details

1160 Industrial Road
Suite 11
San Carlos
94070
United States of America
+16505177288
tlawson@liveleaf.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PR-11036

Study information

Scientific title

Assessment of the therapeutic effect of LiveXtract, a novel plant extract, on the severity and duration of infectious diarrhoea in children and adults: a randomised double-blind placebo-controlled study

Acronym

Study hypothesis

Use of the LiveXtract mixed with oral rehydration solution (ORS) will reduce the duration of diarrhoea compared with ORS alone.

Ethics approval

ICDDR,B Ethical Review Committee, 29/12/2011, PR-11036

Study design

Interventional randomised double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Diarrhoea

Intervention

1. LiveXtract solution mixed with ORS
2. Water mixed with ORS

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Reduction in the severity and duration of diarrhoea, measured as the time the stool is ranked as a 4 or less on the Bristol Stool Scale

Secondary outcome measures

1. Volume of ORS consumed from the time of randomisation to resolution of diarrhoea
2. Number of events and duration of emesis
These outcomes will be monitored every 6 hours for 4 days and ranked with a Visual Analogue Scale of 0 to 10.

Overall trial start date

04/07/2011

Overall trial end date

01/10/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 6 months old to 60 years old
2. Acute watery diarrhoea (for 48 hours or less)

Participant type

Patient

Age group

Mixed

Gender

Male

Target number of participants

The target total recruitment of participants is 736 patients.

Participant exclusion criteria

1. Fever
2. Bloody stool with or without abdominal pain
3. Clinical signs of coexisting severe acute systemic illness
4. Underlying severe chronic disease
5. Severe malnutrition
6. Signs of internal bleeding or black stools
7. Signs of drug abuse
8. Food allergy or other chronic gastrointestinal disease
9. Use of antibiotics or any anti-diarrhoeal medication during the previous 2 weeks
10. Any condition that the admitting physician believes will place the patient at risk if enrolled in the study
11. Participants whose stool cultures show Shigella spp
12. Unable or unwilling to provide informed consent

Recruitment start date

10/05/2012

Recruitment end date

01/10/2017

Locations

Countries of recruitment

Bangladesh

Trial participating centre

Dhaka Hospital
68 Shaheed Tajuddin Ahmed Sarani
Dahaka
1212
Bangladesh

Sponsor information

Organisation

LiveLeaf Inc

Sponsor details

1160 Industrial Road
Suite 11
San Carlos
94070
United States of America
+16505177288
tlawson@liveleaf.com

Sponsor type

Industry

Website

http://liveleaf.com

Funders

Funder type

Industry

Funder name

Liveleaf Inc

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This study is running in two phases: a pilot study for safety data, with submission of the results before April 2015; the second phase will begin in the summer of 2015 and is likely to last 18 months and these data will be submitted to a peer-reviewed journal before the end of 2016.

Intention to publish date

30/04/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes